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Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02325765
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Shanghai Children's Medical Center

Brief Summary:
In this study,the investigators want to determine the corelation between circulating nuclearsome and the development of SIRS occured after congenital cardiac surgery, including the serverity of organ damage and inflamation.

Condition or disease
Congential Cardiac Surgery

Detailed Description:
Blood was collected from study participants at 6 time points; 1) post-anesthesia induction, 2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op hour 72. At each of the 6 time points blood was analyzed for levels of the following:histone,blood routine test , c-reaction protein, procalcitonin, N-terminal pro-brain natriuretic,the hepatorenal function,cardiac function and pulmonary function

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
category of RACHS-2 for cardiac surgery
ASD & VSD repair; VSD repair; Tetralogy repair; Tetralogy repair
category of RACHS-3 for cardiac surgery
DORV repair with or without RV obstruction; AVSD (complete or transitional) repair with or without valve replacement; Coarctation & VSD repair



Primary Outcome Measures :
  1. the perioperation change of histone level [ Time Frame: preoperation to 72 hours after congential cardiac surgery ]

Secondary Outcome Measures :
  1. the perioperation change of c-reaction protein level [ Time Frame: preoperation to 72 hours after congential cardiac surgery ]
  2. the perioperation change of cardiac function [ Time Frame: preoperation to 72 hours after congential cardiac surgery ]
  3. the perioperation change of blood routine test [ Time Frame: preoperation to 72 hours after congential cardiac surgery ]

Biospecimen Retention:   Samples Without DNA
Whole Blood, plasma, serum


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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1-36 months 2.5-15 kilogram accepted congential cardiac surgery
Criteria

Inclusion Criteria:

  • children with congenial heart disease

Exclusion Criteria:

  • Less than 2.5kg
  • Prematurity less than 37 weeks estimated gestational age
  • Renal failure as described by the pediatric RIFLE criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325765


Locations
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China, Shanghai
Shanghai Children's Medical Center
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Children's Medical Center
Investigators
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Study Director: Wei Wang, MD Shanghai Children's Medical Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Children's Medical Center
ClinicalTrials.gov Identifier: NCT02325765     History of Changes
Other Study ID Numbers: EY05.055
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Shanghai Children's Medical Center:
congential cardiac surgery
nuclearsome
systemic inflammation response syndrome